DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a syndesmosis treatment construct, classified in A61B17/0401.
II. Claims 15-18, drawn to a method for syndesmosis treatment construct, classified in A61B17/68.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process of using that product, such as in cardiac anchor suturing.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Furthermore, the search and/or examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Hani Sayed on 06/04/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 5 and 9-11 are objected to because of the following informalities:
Claim 5 line 7 “ a practitioner” is suggested to read “the practitioner” for better antecedent basis.
Claim 5 lines 7-8 “any of various surgical knots” is suggested to read “any of the various surgical knots” for better antecedent basis.
Claim 9 line 2 “the periphery” is suggested to read “a periphery” due to lack of antecedent basis.
Claim 10 line 2 “to a contact surface” is suggested to read “to contact a surface” for better claim language clarity.
Claim 11 line 3 “the second” is suggested to read “the second suture” for clarity of the first and second sutures in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “to contact bone” in line 3 and is unclear if this is the first bone, the second bone, the bone hole, or another bone needing to be introduced. For the purposes of examination, the Office will interpret the claim to mean either of the first bone or second bone.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lyon (US PGPub 2013/0123841) in view of Thornes (US PGPub 2017/0209140).
With regards to claim 1, Lyon discloses (Figures 2-5 and 13-14) a syndesmosis treatment construct 10 (figure 2) configured to be passed through a bone hole across a first bone 2 and a second bone 1 and placed into a cinched configuration whereby the first bone 2 and the second bone 1 are pressed together (paragraphs 4 and 69-74; figure 14), the syndesmosis treatment construct 10 comprising:
a proximal fixator 12 configured to contact the first bone 2 (figure 14);
a distal fixator 16 configured to contact the second bone 1 (figure 14);
a first suture 18 and a second suture 18 (paragraphs 45-46) parallelly looped through the proximal fixator 12 (paragraph 46; figures 2 and 13-14) and oppositely looped through the distal fixator 16 (figures 2 and 13-14) such that a proximal end of the first suture 18 and a proximal end of the second suture 18 extend from the proximal fixator 12 (paragraph 46; figure 2); and
that pulling on the proximal end of the first suture 18 and the proximal end of the second suture 18 causes the cinched configuration (paragraphs 80, 83, and 88; figure 14).
Lyon is silent to a washer disposed between the first bone and the proximal fixator and configured to fixate a distal end of the first suture and a distal end of the second suture.
However, in a similar field of endeavor of syndesmosis, Thornes teaches (Figures 14-16) a washer 60 disposed between the first bone 14 and the proximal fixator 68 and configured to fixate a distal end of the first suture 70 (figure 15; paragraph 104).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the construct of Lyon to include a washer as taught by Thornes for the purpose of defining maximum flexibility of the washer and increase the tolerance for non-aligned drill holes and the like (paragraph 118 of Thornes).
The combination of Lyon in view of Thornes results in the washer (Thornes: 60) between the first bone (Lyon: 2) and the proximal fixator (Lyon: 12; akin to Thornes’s 68) and configured to fixate a distal end of the first suture (Lyon: 18) and a distal end of the second suture (Lyon: 18), such that pulling on the proximal end of the first suture (Lyon: 18) and the proximal end of the second suture (Lyon: 18) causes the cinched configuration (Lyon: figure 14).
With regards to claim 2, the combination of Lyon/Thornes disclose wherein the proximal fixator (Lyon: 12) and the washer (Thornes: 60) are configured to be seated within an aperture (Lyon: 50) of a bone fusion plate (Lyon: 14; paragraphs 41-43).
With regards to claim 3, the combination of Lyon/Thornes disclose wherein the proximal fixator (Lyon: 12) is a cone-shaped member (Lyon: figure 3 – proximal fixator 12 is cone-shaped) configured to contact a disk portion (Thornes: round undersurface of washer 60) comprising the washer (Thornes: 60), the disk portion being configured to contact bone (Lyon: 2; (see 112(b) rejection above) in lieu of being seated within the aperture (Lyon: 50; functional limitation - disk portion of Thornes is capable of contacting the bone 2 of Lyon in lieu of being seated within the aperture 50 of Lyon).
With regards to claim 12, Lyon further discloses wherein the distal fixator 16 comprises an oblong-shaped member (figure 5) having a first aperture 70 and a second aperture 72 and is configured to be drawn through the bone hole (figures 13-14 – functional limitation – distal fixator 16 is capable of being drawn through the bone hole as seen via the sutures 18 being drawn through the bone hole in figure 13) before the first bone 2 and the second bone 1 are cinched together (figure 14).
With regards to claim 13, Lyon further discloses wherein the first suture 18 extends distally through the first aperture 70 and extends proximally through the second aperture 72, and wherein the second suture 18 extends distally through the second aperture 72 and then extends proximally through the first aperture 70 (paragraph 46; figure 2).
With regards to claim 14, Lyon further discloses wherein the first suture 18 and the second suture 18 loop oppositely through the first aperture 70 and the second aperture 72 (paragraph 46; figure 2) to inhibit rotation of the distal fixator 16 during cinching the syndesmosis treatment construct (figure 14 – distal fixator 16 is secured on the bone 1 and cinched, therefore inhibiting rotation of the distal fixator 16; paragraphs 69-74 – stabilization procedure).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lyon in view of Thornes, and further in view of Fritzinger et al. (US PGPub 2013/0172944), hereinafter known as “Fritzinger.”
With regards to claims 4 and 5, Lyon/Thornes disclose the syndesmosis treatment construct of claim 1. Lyon further discloses wherein the proximal fixator 12 includes a first aperture 22 and a second aperture 22 (figure 2 – see two apertures 22 separated by bar 30; paragraphs 38 and 46). The combination is silent to wherein the proximal fixator includes a third aperture and a fourth aperture that are configured to facilitate a practitioner forming various surgical knots to maintain the cinched configuration (claim 4); and wherein the proximal end of the first suture is drawn proximally through the first aperture and passed distally through the fourth aperture before exiting between the washer and the proximal fixator, and wherein the proximal end of the second suture is drawn proximally through the second aperture and passed through the third aperture before exiting between the washer and the proximal fixator, the exiting proximal end of the first suture and the exiting proximal end of the second suture being configured to facilitate a practitioner forming any of various surgical knots to maintain the cinched configuration (claim 5).
However, in a similar field of endeavor of syndesmosis, Fritzinger teaches (Figures 10-11, 17-18) wherein the proximal fixator 132 includes a first aperture 150, a second aperture 150, a third aperture 150 and a fourth aperture 150 that are configured to facilitate a practitioner forming various surgical knots to maintain the cinched configuration (paragraph 47 and figure 17 discloses the knot 250 being tied, paragraph 48 and figure 18 discloses the use of sutures threading through passages 150 of the proximal fixator 132); and
wherein the proximal end of the first suture 312 is drawn proximally through the first aperture 150 and passed distally through the fourth aperture 150 before exiting, and wherein the proximal end of the second suture 312 is drawn proximally through the second aperture 150 and passed through the third aperture 150 before exiting, the exiting proximal end of the first suture 312 and the exiting proximal end of the second suture 312 being configured to facilitate a practitioner forming any of various surgical knots to maintain the cinched configuration (paragraph 48; see annotated figure 18 below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syndesmosis treatment construct of Lyon/Thornes to include a third aperture and a fourth aperture on the proximal fixator as taught by Fritzinger for the purpose of further fixating the bone anchor and maintaining a strong anchor.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 6-11 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 6-11 of prior U.S. Patent No. 11,426,205. This is a statutory double patenting rejection. See claim mapping table below.
Application 18/942,270
US Patent 11,426,205
Claim 6
Claims 1 and 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12-14 of U.S. Patent No. 11,426,205. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application encompass similar limitations from the claims of US Patent 11,426,205. See claim mapping table below.
Application 18/942,270
US Patent 11,426,205
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 06/11/2026
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